Application Information Requirements for ARTG Inclusion in Australia

1. Key takeaways

For any medical device or IVD seeking inclusion on the Australian Register of Therapeutic Goods (ARTG), the single authoritative checklist of what must accompany the application is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018, registered as F2018L01410. Its retrieval logic is extremely simple once it is understood: the applicant first locates the Schedule and the Part that correspond to the device class, and then reads the two columns of documents required by that line item. Column 3 contains quality management system evidence, while column 4 contains product assessment evidence, and the application must be supported by one document drawn from each column.

• The Determination is the only legal source of the information requirements, and every obligation can be traced to a specific Schedule, Part and item number.
• Column 3, covering the quality management system, and column 4, covering product assessment, must each be satisfied with one document issued or recognised by the authority named in column 2.
• Section 8 allows documents required for a higher class to be submitted in place of the documents required for the applicable class, provided the substitution logic is explained in the application.
• Section 10 requires all documents to be in English or accompanied by a certified translation; Chinese-language technical files submitted directly do not constitute a valid submission.
• The current compilation is version 13 (F2025C01150), which took effect on 1 December 2025 and rewrote parts of the Schedule 1 structure.
• The 2024 and 2025 amendments reshaped Schedule 1 Parts 2, 3 and 4, so item numbers must be re-verified against the current compilation before every submission.

2. Legal basis

The legal basis begins with the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018, registered as F2018L01410. The authorising provision is section 3 of the instrument, which draws its power from sections 41FDB(7) and (8) of the Therapeutic Goods Act 1989 (Act No. 21, 1990). The Determination was registered on 9 October 2018 and took effect on 10 October 2018. The current compilation is version 13 (F2025C01150), effective from 1 December 2025.

The operative structure of the body text is organised by device type. Section 5 applies to devices that are not IVDs, section 6 applies to IVDs, section 6A applies to export-only devices, section 7 applies to systems or procedure packs (SOPP), section 8 permits documents required for a higher class to be submitted in substitution, section 9 addresses cases where no information requirement exists, and section 10 requires documents to be in English or accompanied by a certified translation.

The schedules allocate the requirements by class. In Schedule 1, which covers non-IVD devices, Part 1 Division 1 applies to Class I devices that are neither sterile nor have a measuring function, and Division 2 applies to Class I devices that are sterile or have a measuring function; Part 2 covers Class IIa, Part 3 covers Class IIb and Part 4 covers Class III. In Schedule 2, which covers IVDs, Part 1A applies to Class 1, Part 1 applies to Class 2, Part 2 applies to Class 3, Part 3 applies to Class 4 and Part 4 applies to Class 4 in-house IVDs. Schedule 2A covers export-only devices and Schedule 3 covers systems or procedure packs.

The evidence logic operates through sections 5(1)(a)(b) and 6 in combination with the schedules. Each item is issued or recognised by the regulatory authority identified in column 2, and the applicant must submit one document from column 3, covering quality management system evidence, and one document from column 4, covering product assessment evidence.

The amendment history confirms the pace of change: F2024L00760 was registered on 24 June 2024 and took effect on 1 July 2024, amending sections 4 and 5, rewriting Schedule 1 Part 2 and Part 3 and deleting Part 4 Division 1; F2024L01328 was registered on 18 October 2024 and took effect on 19 October 2024; F2024L01674 was registered on 17 December 2024 and took effect on 18 December 2024; and F2025L01322 was registered on 30 October 2025 and took effect on 1 December 2025.

3. Expert insights

Insight 1: the two-column structure is the core paradigm of Australian evidence gathering. Every requirement is composed of the two columns, namely quality system evidence plus product evidence. A company that prepares only product-side material, for example submitting only a CE technical documentation assessment certificate, will be missing the column 3 quality system documents. A company that prepares only system-side material, for example submitting only ISO 13485 certification, will be missing the column 4 product assessment documents.

Insight 2: section 8 permits upward substitution. Documents required for a higher class may be submitted in place of those required for the applicable class. This is a cost-reduction pathway for products that already hold high-level overseas approvals, but the substitution logic must be explained in the application itself.

Insight 3: the language requirement in section 10 is routinely underestimated. Documents must be in English or accompanied by a certified translation. Chinese technical documents submitted directly do not constitute a valid submission, and the method of certifying the translation must align with what the TGA expects.

4. Practical recommendations

• Build a mapping table running from device class to Schedule, Part, item number and the two columns of documents, and use it as the cover index of every application.
• Number and archive the documents for each column separately, and cross-reference them to the specific item numbers in the application, reducing the reviewer’s search effort.
• Arrange certified translations for non-English material early, and build the translation lead time into the project schedule.
• After each compilation update, re-verify whether the item numbers in the mapping table have shifted; version 13 has already rewritten parts of the Schedule 1 structure.

5. Verification checklist

• □ The applicable Schedule and Part have been located by device class
• □ Column 3 (system) and column 4 (product) documents have been prepared separately
• □ Non-English material has completed certified translation
• □ The feasibility of upward substitution under section 8 has been assessed
• □ The mapping table has been re-verified against compilation version 13

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team prepares TGA-compliant CTOs and evidence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com